ISLET Act
Sponsored By: Senator Mike Lee
Introduced
Summary
Classifies human cadaveric islets as organs for transplantation. This bill would treat islets the same way the law treats organs, not as drugs, biological products, or standard cell or tissue products, and it sets deadlines for HHS to update rules and report progress.
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- Families and patients: People awaiting islet transplants would be covered by organ-transplant rules, which changes which federal standards apply to their treatment.
- Transplant centers and clinicians: Hospitals, transplant programs, and organ procurement groups would follow organ transplantation regulations for handling and using cadaveric islets instead of drug, biologic, or HCT/P rules.
- Federal agencies: The Department of Health and Human Services must revise regulations under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act within 1 year and send a progress report to Congress within 6 months.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
New rules for islet transplants
If enacted, human cadaveric islets would be treated like transplant organs such as the pancreas. The bill would say islets are not drugs, biological products, or HCT/Ps. The Secretary of Health and Human Services would have to update HHS and FDA rules within 1 year. The Secretary would have to report progress to Congress within 6 months. These changes could affect transplant centers, organ procurement groups, manufacturers, clinicians, and patients seeking islet transplants.
Sponsors & CoSponsors
Sponsor
Mike Lee
UT • R
Cosponsors
Ted Budd
NC • R
Sponsored 11/5/2025
Roll Call Votes
No roll call votes available for this bill.
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